The present invention relates to an improved process using electrostimulation for treating obesity, especially morbid obesity, and other syndromes related to motor disorders of the stomach. The improved method of this invention provides electrostimulation on the lesser curvature of the stomach which provides improved control of obesity and other syndromes related to motor disorders of the stomach.
The modern surgical orientation with regard to obesity generally entails the reduction of gastric compliance, with the aim of limiting the subject""s ability to ingest food, or of reducing the food absorption surface by shortening or bypassing part of the digestive canal; both aims are sought in some surgical procedures. Until recently, surgery was the only therapy that ensures real results in patients who have exceeded obesity values close to or greater than about 40 BMI (ratio of weight to the square of the height).
All of the major surgical procedures (e.g., removal or blocking off of a portion of the stomach) currently in use have some immediate and/or delayed risks. Thus, surgery is usually considered as an extreme solution when all less invasive procedures fail. Furthermore, even surgical treatment fails in some cases, thereby requiring the surgeon to restore the original anatomical situation.
More recently, methods have been successfully employed whereby an electrostimulation device is implanted on the stomach wall. For example, U.S. Pat. No. 5,423,872 (Jun. 13,1995) provided a process for the treatment of obesity and related disorder employing an electrostimulator or pacemaker attached to the antrum or greater curvature of the stomach. U.S. Pat. No. 5,690,691 (Nov. 25, 1997) provided a portable or implantable gastric pacemaker including multiple electrodes positionable on the inner or outer surface of an organ in the gastrointestinal tract which are individually programmed to deliver a phased electrical stimulation to pace peristaltic movement of material through the gastrointestinal tract. Although these methods have generally been successful, it is still desirable to provide improved methods for such treatments. The present invention provides such an improved process.
The present invention provides a process for treating obesity and/or related motor disorders by providing an electrostimulation or pacemaker device attached to the lesser curvature of the stomach. Preferably, the electrostimulation or pacemaker device provides electrostimulation to the lower or distal end of the lesser curvature (i.e., towards the pylorus). Preferably, the process of this invention employs stimulation of the lesser curvature at a rate of about 2 to about 14 pulses/minute with each pulse lasting about 0.5 to about 4 seconds such that there is a pause of about 3 to about 30 between the pulses. More preferably, the pulse rate is about 12 pulses/minute with each pulse lasting about 2 seconds with a pause of about 3 seconds between pulses. Preferably, the pulse amplitude is about 0.5 to about 15 milliamps. More preferable, each pulse consists of a train of micro-bursts with a frequency of about 5 to about 100 secxe2x88x921.
The process of the present invention involves treatment of obesity and other syndromes related to motor disorders of the stomach of a patient. The process comprises artificially altering, using sequential electrical pulses for preset periods of time, the natural gastric motility of the patient to prevent or slow down stomach emptying, thereby slowing food transit through the digestive system.
The present invention provides a method for treatment of a motor disorder of a patient""s stomach, said method comprising implanting an electrostimulation device comprising one or more electrostimulation leads and an electrical connector for attachment to a pulse generator such that the one or more electrostimulation leads are attached to, or adjacent to, lesser curvature of the patient""s stomach, whereby electrical stimulation can be provided to the lesser curvature through the one or more electrostimulation leads; and supplying electrical stimulation to the lesser curvature through the one or more electrostimulation leads.
This invention also provides a method for treatment of a motor disorder of a patient""s stomach, said method comprising implanting an electrostimulation device comprising an elongated body with a proximal and a distal end and having one or more electrostimulation leads and an electrical connector for attachment to a pulse generator at the proximal end such that the one or more electrostimulation leads are attached to, or adjacent to, lesser curvature of the patient""s stomach, whereby electrical stimulation can be provided to the lesser curvature through the one or more electrostimulation leads and whereby, once the electrostimulation device is implanted, the one or more electrostimulation leads are at the distal end of the elongated body; and supplying electrical stimulation to the lesser curvature through the one or more electrostimulation leads.